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Molecular Subgroup Analysis of Clinical Outcomes in a Phase 3 Study of Gemcitabine and Oxaliplatin with or without Erlotinib in Advanced Biliary Tract Cancer

 Seung Tae Kim  ;  Kee-Taek Jang  ;  Jeeyun Lee  ;  Heung-Moon Jang  ;  Hye-Jin Choi  ;  Hye-Lim Jang  ;  Se Hoon Park  ;  Young Suk Park  ;  Ho Yeong Lim  ;  Won Ki Kang  ;  Joon Oh Park 
 TRANSLATIONAL ONCOLOGY, Vol.8(1) : 40-46, 2015 
Journal Title
Issue Date
Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Biliary Tract Neoplasms/drug therapy* ; Biliary Tract Neoplasms/epidemiology ; Biliary Tract Neoplasms/pathology ; Cholangiocarcinoma/drug therapy* ; Cholangiocarcinoma/epidemiology ; Cholangiocarcinoma/pathology ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives* ; Deoxycytidine/therapeutic use ; Disease Progression ; Disease-Free Survival ; Erlotinib Hydrochloride ; Female ; Gallbladder Neoplasms/drug therapy* ; Gallbladder Neoplasms/epidemiology ; Gallbladder Neoplasms/pathology ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Staging ; Organoplatinum Compounds/administration & dosage ; Organoplatinum Compounds/adverse effects ; Organoplatinum Compounds/therapeutic use* ; Quinazolines/administration & dosage ; Quinazolines/adverse effects ; Quinazolines/therapeutic use*
BACKGROUND: We previously reported that the addition of erlotinib to gemcitabine and oxaliplatin (GEMOX) resulted in greater antitumor activity and might be a treatment option for patients with biliary tract cancers (BTCs). Molecular subgroup analysis of treatment outcomes in patients who had specimens available for analysis was undertaken. METHODS: Epidermal growth factor receptor (EGFR), KRAS, and PIK3CA mutations were evaluated using peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp reactions. Survival and response rates (RRs) were analyzed according to the mutational status. Sixty-four patients (48.1%) were available for mutational analysis in the chemotherapy alone group and 61 (45.1%) in the chemotherapy plus erlotinib group. RESULTS: 1.6% (2/116) harbored an EGFR mutation (2 patients; exon 20), 9.6% (12/121) harbored a KRAS mutation (12 patients; exon 2), and 9.6% (12/118) harbored a PIK3CA mutation (10 patients, exon 9 and 2 patients, exon 20). The addition of erlotinib to GEMOX in patients with KRAS wild-type disease (n = 109) resulted in significant improvements in overall response compared with GEMOX alone (30.2% vs 12.5%, P = .024). In 95 patients with both wild-type KRAS and PIK3CA, there was evidence of a benefit associated with the addition of erlotinib to GEMOX with respect to RR as compared with GEMOX alone (P = .04). CONCLUSION: This study demonstrates that KRAS mutational status might be considered a predictive biomarker for the response to erlotinib in BTCs. Additionally, the mutation status of PIK3CA may be a determinant for adding erlotinib to chemotherapy in KRAS wild-type BTCs.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Hye Jin(최혜진) ORCID logo https://orcid.org/0000-0001-5917-1400
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